Expired Study
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Ft. Myers, Florida 33901


Purpose:

The purpose of this study is to compare the rate and extent of absorption of Dr. Reddy's Desloratadine 5 mg tablet to that of Clarinex® 5 mg tablet in healthy subjects under fasting conditions.


Study summary:

A Randomized, Single-Dose, Two-Way Crossover Relative Bioavailability Study of Desloratadine 5 mg Tablet in Fasted Normal,Healthy subjects.


Criteria:

Inclusion Criteria: - Is the individual a healthy, normal adult man and women who volunteers to participate? - Is s/he within 18 and 45 years of age, inclusive? - Is his/her BMI between 19 and 30, inclusive? - Is she willing to avoid pregnancy by abstaining from sexual intercourse with a non-sterile male partner, or by the use one of the following methods: diaphragm + spermicide or condom + spermicide (at least 14 days before dosing), intra-uterine contraceptive device or hormonal contraceptives (at least 4 weeks prior to dosing), or has she been surgically sterile or post-menopausal at least six months prior to entering into the study? - Is s/he considered reliable and capable of understanding his/her responsibility and role in the study? - Has s/he provided written informed consent? A no answer to any of the above questions indicates that the individual is ineligible for enrollment Exclusion Criteria: Does the individual have a history of allergy or hypersensitivity to desloratadine? - Does s/he have clinically significant laboratory abnormalities that would interfere with the conduct or interpretation of the study or jeopardize his/her safety? - Does s/he have significant history or clinical evidence of auto-immune, cardiovascular, gastrointestinal, hematological, hematopoietic, hepatic, neurological, ongoing infection, pancreatic, or renal diseases that would interfere with the conduct or interpretation of the study or jeopardize his/her safety? - Is she nursing? - Does s/he have serious psychological illness? - Does s/he have significant history (within the past year) or clinical evidence of alcohol or drug abuse? - Does s/he have a positive urine drug screen or a positive HIV-1, or hepatitis B or C screen, or a positive pregnancy test? - Is s/he unable to refrain from the use of alcohol or xanthine-containing foods or beverages during periods beginning 48 hours prior to study drug administration and ending when the last blood sample has been taken in each study period? . - Has s/he used any prescription drug, other than hormonal contraceptives, during the 14-day period prior to study initiation, or any OTC drug during the 72-hour period preceding study initiation? - Is s/he unable to refrain from the use of all concomitant medications, other than hormonal contraceptives, during the study? - Has s/he donated or lost blood, or participated in a clinical study which involved the withdrawal of a large volume of blood (480 mL or more), during the six week period preceding study initiation? - Has s/he donated plasma during the two week period preceding study initiation? - Has s/he used any tobacco products in the 3 months preceding drug administration? - Has s/he received an investigational drug during the 30 day period preceding study initiation? A yes answer to any of the above questions indicates that the individual is ineligible for enrollment.


NCT ID:

NCT01314339


Primary Contact:

Principal Investigator
Antonio R. Pizarro, M.D.,
SFBC Ft. Myers, Inc


Backup Contact:

N/A


Location Contact:

Ft. Myers, Florida 33901
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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